NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]

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NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET [PROFICIENT RX LP]
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NDC 63187-344-24
Set ID 4eab4344-d95e-4b19-a21e-9c8ad033863a
Category HUMAN OTC DRUG LABEL
Packager Proficient Rx LP
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredient (in each tablet)

    •
    Pseudoephedrine HCl 30 mg
  • Purpose

    •
    Nasal Congestant
  • Use(s)

    •
    temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    •
    temporarily restores freer breathing through the nose
  • Warnings

    Do not use

    •
    if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or 2 weeks after stoppin the MAOI drug.  If you do not know if your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    •
    diabetes
    •
    high blood pressure
    •
    heart disease
    •
    thyroid disease
    •
    trouble urinating due to an enlarged prostate gland

    When using this product

    •
    do not use more than directed

    Stop use and ask a doctor if

    •
    nervousness, dizziness, or sleeplessness occur
    •
    symptoms do not improve within 7 days or occur with fever

    If pregnant or breast-feeding,

    •
    ask a health professional before use.

    Keep out of reach of children.

    •
    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
  • Directions

     adults and children
    12 years and older 

     take 2 tablets every 4 to 6 hours;
    do not take more than 8 tablets in
    24 hours 

     children ages 6 to 12 years

     take 1 tablet every 4 to 6 hours;
    do not take more than 4 tablets in
    24 hours 

     children under 6 years

     do not use
  • Other information

    •
    store at room temperature 15º-30ºC (59º-86ºF)
  • Inactive ingredients

    •
    calcium sulfate, carnauba wax, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silica, stearic acid, sugar and titanium dioxide
  • Questions or comments?

    1-800-645-2158

  • Principal Display Panel

    Rugby®

    compare to Sudafed®

    Decongestant active ingredient*

    NDC 63187-344-24

    Nasal Decongestant

    pseudoephedrine HCl 30 mg

    Temporarily relieves:

    • nasal congestion due to cold & allergies withoout drowsiness

    24 tablets, 30 mg each

    TAMPER EVIDENT: SAFETY SEALED: DO NOT USE IF BLISTER SEAL IS BROKEN

    Rev 04/13

    R-29

    DISTRIBUTED BY:
    Rugby Laboratories
    31778 Enterprise Drive
    Livonia, MI 48150
    www.rugbylaboratories.com

    Repackaged by:
    Proficient Rx LP
    Thousand Oaks, CA 91320

    63187-344-24
  • INGREDIENTS AND APPEARANCE
    NASAL DECONGESTANT 
    pseudoephedrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-344(NDC:0536-3607)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    KAOLIN (UNII: 24H4NWX5CO)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)  
    ACER SACCHARUM POLLEN (UNII: V38QUQ7861)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 1004
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-344-241 in 1 CARTON03/03/2014
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/29/2012
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(63187-344)
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